SC1 Handheld Ultrasound Imaging System (Model: SC1)
K-Number: K210468 · 2021-07-23
Device Summary
Frequently Asked Questions
What is the SC1 Handheld Ultrasound Imaging System (Model: SC1)?
SC1 Handheld Ultrasound Imaging System (Model: SC1) is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Fcu Co., Ltd.. The 510(k) number is K210468.
When did SC1 Handheld Ultrasound Imaging System (Model: SC1) receive FDA 510(k) clearance?
SC1 Handheld Ultrasound Imaging System (Model: SC1) received FDA 510(k) clearance on 2021-07-23, under 510(k) number K210468.
Who is the listed applicant for SC1 Handheld Ultrasound Imaging System (Model: SC1)?
The FDA 510(k) record lists Fcu Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SC1 Handheld Ultrasound Imaging System (Model: SC1)?
The FDA product code for SC1 Handheld Ultrasound Imaging System (Model: SC1) is IYO.
Other records listing Fcu Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IYO)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.